FDA applicant

Bison Medical Co, Ltd.

Guemcheon Gu, KR3 decisions2015–20160 recalls

FDA records 3 decisions for Bison Medical Co, Ltd. (Guemcheon Gu, KR) from 2015 to 2016: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Bison Medical Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2015high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Bison Medical Co, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bison Medical Co, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bison”

FDA records each applicant name separately; these may or may not be the same firm.

Bison-Lee Co. 1

Bison Medical Co, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bison”